TALAZOPARIB TOSYLATE - Generic Drug Details

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What are the generic drug sources for talazoparib tosylate and what is the scope of freedom to operate?

Talazoparib tosylate is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Talazoparib tosylate has ninety-five patent family members in thirty-one countries.

Two suppliers are listed for this compound.

Summary for TALAZOPARIB TOSYLATE

International Patents:	95
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	10
Patent Applications:	95
DailyMed Link:	TALAZOPARIB TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TALAZOPARIB TOSYLATE

Generic Entry Dates for TALAZOPARIB TOSYLATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL
Generic Entry Dates for TALAZOPARIB TOSYLATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TALAZOPARIB TOSYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stanford University	Phase 2
Pfizer	Phase 1
Roswell Park Cancer Institute	Phase 1

See all TALAZOPARIB TOSYLATE clinical trials

Pharmacology for TALAZOPARIB TOSYLATE

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TALAZOPARIB TOSYLATE

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TALAZOPARIB TOSYLATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-002	Mar 7, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for TALAZOPARIB TOSYLATE

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Country	Patent Number	Title	Estimated Expiration
Mexico	2011001328	INHIBIDORES DE DIHIDROPIRIDOFTALAZINONA DE POLI (ADP-RIBOSA) POLIMERASA (PARP). (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERA SE (PARP).)	⤷ Sign Up
South Korea	20190120458	결정질의 (8S,9R)-5-플루오로-8--9-(1-메틸-1H-1,2,4-트리아졸-5-일)-8,9-디하이드로-2H-피리도[4,3,2-DE]프탈라진-3(7H)-온 토실레이트 염 (8S9R-5--8-4--9-1--1H-124--5--89--2H-[432-DE]-37H- CRYSTALLINE 8S9R-5-FLUORO-8-4-FLUOROPHENYL-9-1-METHYL-1H-124-TRIAZOL-5-YL-89-DIHYDRO-2H-PYRIDO[432-DE]PHTHALAZIN-37H-ONE TOSYLATE SALT)	⤷ Sign Up
Japan	2013540158		⤷ Sign Up
Lithuania	C2767537		⤷ Sign Up
Australia	2009279944	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)	⤷ Sign Up
South Africa	201100897	DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE(PARP)	⤷ Sign Up
New Zealand	591166	DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TALAZOPARIB TOSYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	1990055-4	Sweden	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537	54/2019	Austria	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1377 (MITTEILUNG) 20190624
2767537	PA2019522	Lithuania	⤷ Sign Up	PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	2019/060	Ireland	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; NAT REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620; FIRST REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620 (20200708)
2767537	C02767537/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67141 12.12.2019
2767537	SPC/GB19/070	United Kingdom	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS THE TOSYLATE SALT; REGISTERED: UK EU/1/19/1377 (NI) 20190624; UK PLGB00057-1672 20190624; UK PLGB00057-1673 20190624
2767537	2019C/551	Belgium	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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